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A Profile of the Radiation Source Sector

Committee on Radiation Source Use and Replacement

The National Academies

Washington, D.C.

July 10, 2006

Grant Malkoske, P.Eng.

Chairman, ISSPA and GIPA

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Innovation in radioisotope applicationsInnovation in radioisotope applications

Radiation technology is used to improve global health

Radiation technology provides important industrial benefits

Radioisotopes are at the heart of industry safety systems and counter-terrorism

The radioisotope sector is broad, diverse with a culture of safety and security.

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The radioisotope sector profileThe radioisotope sector profile

Why are radiation sources used? Dose penetration ability provides for development of

medical devices that cannot be sterilized by other means

Ability to perform in aggressive environments precludes known alternative technologies

Throughput performance characteristics provide a cost effective technology

Regulatory oversight provides for safe and secure application of technology

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The radioisotope sector profileThe radioisotope sector profile

What are radiation sources used for? Medical treatment and diagnostics Sterilization of single-use medical devices Research and development Food safety and agricultural applications Industrial and safety applications Law enforcement & counterterrorism

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Cancer TreatmentCancer Treatment U.N. declares that cancer is a “silent

crisis” in the developing world and the need to treat cancer is rising Cancer takes more lives than HIV/AIDS,

TB and malaria, combined

Cobalt-60 teletherapy delivers 15 million treatments annually worldwide in 50 countries Over 1200 units installed globally

Brachytherapy techniques employ Iridium-192, Iodine-125, Palladium-103, Strontium-90 for novel treatment applications

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Blood Irradiator Treat blood to prevent TA-GVHD

Over 750 units installed in 50 countries

High throughput and dose delivery compared to x-ray technology

Reliant on availability of high activity Caesium-137 sources

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Sterile Single-Use Medical DevicesSterile Single-Use Medical Devices Cobalt-60 radiation sources are

depended upon to sterilize some 45% of all single-use medical supplies in the world

40% in US

An estimated 80% of all surgeons’ gloves are sterilized with cobalt-60

50% of the world’s sterile single-use medical devices come from the US

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Cobalt-60 Sterilization CapacityCobalt-60 Sterilization Capacity Sterilization capacity is based on projected demand

(growing 7-15% annually) and isotope decay (currently 19 MCi annually)

No excess cobalt-60 is maintained in irradiators Irradiators operate on a 24/7 schedule to optimize utilization of

cobalt-60 There are approximately 152 MCI cobalt-60 installed in the

US Increase in sterilization demand for Health and Human Services

would require additional cobalt-60 Used to sterilize over 200MM cu. ft. of single-use medical devices

annually

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Medical Device InventoriesMedical Device Inventories

Most medical device companies practice “Just In Time (JIT)” manufacturing

Sterile device inventories in the order of 30 to 40 days are common

Low inventories help control healthcare costs Disruption of the supply of cobalt-60 will result in

backorders of sterile single-use devices

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Impact on HealthcareImpact on Healthcare

Only healthcare providers can define life threatening medical conditions

Backorders will result in shortages of critical medical devices

Healthcare facilities do not have substitutes for these medical devices

Shortages of medical devices can result in irreversible medical complications including death

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Importance of cobalt-60Importance of cobalt-60 Certain products can only be

sterilized with cobalt-60: Biological materials: tissue for

transplant, plasma, serum

Alcohol swabs

Sealed medical devices: used for blood collection, endoscopic procedures, and for use with certain catheters

Many products are optimally sterilized with cobalt-60

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Acupuncture and electrolysis needlesAstronaut foodBaby pacifiers, baby bottlesBandagesBeakersBeefBioassay dishesBladder irrigation setsBlanketsBlood agar (processed in frozen state)Blood collection tubesBone jointsBottle and cupsBrushesBurn ointments, burn padsCatheter collarsCentrifuge tubes, clampsCoffeeContact lens, saline solutionCulture flasks, tubesCosmeticsDiagnostic stripsDialysis unitsDialyzersDisposable thermometersDog chewsDonor setsDrainage systemsDressings and dressing pads

ElectrodesEnzymesEye droppers and eye padsFilter clamps and filtersFirst aid packsFruits and vegetablesGlove powderHypodermic syringesImplantsInfusion setsIntravenous setsIron oxide pigmentJuice containersKidney transplant kitsLaboratory animal beddingLaboratory animal feedLaboratory diagnostic kitsLab wareLubricating jellyMastitis test kitNeedle counting systemsNeonatal diapersNutraceuticalsOxygenatorsPet foodPetri dishesPharmaceuticalsPipettesPoultry

Saline solution Scalpel bladesSeafoodSerum tubesShampooSpecimen containersSpicesStopcocksSurgical gloves, gowns, kits and drapesSurgical needlesSurgical scrub brushes, surgical setsSurgical marking pensSurgical staplersSuture removal tray and suturesSwabs and swab special kitsTalcTamponsTest tubesTowelsTracheal suction kitsTransfusion setsTransplant carrying containersTubing and tube connectorsUrine bagsUrine sample collection kitsValvesVascular graftsWaterAnd more

Sampling of products sterilized with cobalt-60

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Production Irradiator

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Other Sterilization MethodsOther Sterilization Methods Devices are designed specifically for cobalt-60

sterilization Other sterilization methods may require a design and/or

material changes Other sterilization methods would require evaluation and

testing Changes to products and/or sterilization methods

require a new submission to FDA Testing to determine appropriate changes, followed by

submission review and approvals take months and years and add costs to health care system

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Food Safety Relied upon to enhance food safety &

preservation• Used by fruit-producing nations to control

export of crop-destroying insects

• Used by food producers to eliminate microbes from food packaging

• Used to eliminate pathogens and extend shelf-life of many foods

– Well over 80% of spices used in instant noodles in Asia are irradiated.

Food Safety and Agricultural Applications

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Food Safety and Agricultural ApplicationsFood Safety and Agricultural Applications Agriculture

Crop production (fertilizer efficiency, moisture content) Crop improvement (disease resistant crops, improved yields) Animal husbandry (feeding, reproduction, disease diagnosis) Insect control

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Industrial ApplicationsIndustrial Applications

Radiography Oil well logging Gauges

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RadiographyRadiography Well established NDT method

Welds, castings, engines, pipelines

Fixed, portable and self propelled equipment for

various applications

Equipment is rugged and designed to use in remote and hostile environments

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Radiography equipmentRadiography equipment

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Oil well logging Aggressive environments in drilling operation preclude use of

known alternative technologies

Gauges Tracer investigations (flow rates, by-pass streams, process

mixing, leak detection, wear & corrosion) Metal coating, ore processing Thickness, density, height requirements Statistical measurement precision from sources greatly

exceeds other technologies enabling cost control and minimizing process waste

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Law Enforcement & CounterterrorismLaw Enforcement & Counterterrorism

Explosives detection at airports and other monitoring points

Drug and gas detection Crime analysis Finger printing, counterfeiting

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Safety and Security of Radiation SourcesSafety and Security of Radiation Sources Continuous design development to improve source

safety in the case of fire or explosion (e.g. dispersion resistant designs)

Industry engages in life-cycle management activities to minimize the amount of unused material in circulation and avoid loss of control

Extensive monitoring and tracking is associated with movements of these materials to avoid the risk of them being diverted

Security measures meet IAEA guidelines and USNRC requirements

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RecommendationIndustry recommends that the National Academies Committee consider the following perspectives in performing the study:

RecommendationIndustry recommends that the National Academies Committee consider the following perspectives in performing the study:

Radiation sources are generally selected as they provide the only or optimal technology for the intended benefit Other technologies may be ineffective or add cost burden

Engage industry groups and users in a broad based consultation To understand the technology pull, benefits and risks